Biosimilars: Policy, Practice, and Post Marketing Surveillance to Support Treatment and Coverage Decisions - DEC. 15-16, 2020 | VIRTUAL - AMCP

 
Biosimilars: Policy, Practice, and Post Marketing Surveillance to Support Treatment and Coverage Decisions - DEC. 15-16, 2020 | VIRTUAL - AMCP
PA R T N E R S H I P
                                      FORUM
                                      No. 3   2020

Biosimilars: Policy, Practice, and
Post Marketing Surveillance to Support
Treatment and Coverage Decisions
DEC. 15–16, 2020 | VIRTUAL

                                                 as of Jan. 4, 2021
Biosimilars: Policy, Practice, and Post Marketing Surveillance to Support Treatment and Coverage Decisions - DEC. 15-16, 2020 | VIRTUAL - AMCP
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS

WELCOME

                               Welcome to AMCP’s final Partnership Forum of 2020. We appreciate that you will be spending the next
                               two days with us to identify key actions that can support the further development and use of biosimilars
                               in the U.S. health care system.

                               Biologics, including biosimilars, offer a critical opportunity for expanding patient access to medicines
                               while simultaneously reducing health care costs through a competitive marketplace. However, biosimilar
                               adoption in the United States is significantly slower than in other countries.

                               AMCP’s focus is on addressing the practice and regulatory hurdles that hinder utilization of biosimilars
                               and ensuring health care decision makers have the evidence they need to evaluate the safety and
                               effectiveness of these therapies.

                               During this AMCP Partnership Forum, we will discuss the policy, practice, and post-marketing
                               surveillance activities that support treatment and coverage decisions for biosimilars. We will also analyze
                               the barriers to biosimilar adoption, including gaps in provider knowledge and the need to generate
                               more real-world evidence to inform treatment and coverage decisions.

                               To facilitate a successful dialogue, I am pleased to welcome a variety of participants to this AMCP
                               Partnership Forum, including payers, pharmacists, integrated delivery system leaders, health economists
                               and analysts, academicians, patient care providers, pharmaceutical manufacturers, and other key
                               decision makers.

                               This AMCP Partnership Forum would not be possible without the generous support of our sponsors:
                               Amgen, the Association for Accessible Medicines, Boehringer Ingelheim, Fresenius Kabi, Johnson &
                               Johnson, Novo Nordisk, Pfizer, Sandoz, and Takeda.

                               Following this event, AMCP will produce proceedings documenting our findings and recommendations
                               in an upcoming issue of AMCP’s Journal of Managed Care + Specialty Pharmacy, which is widely
                               disseminated to decision makers around the country.

                               I look forward to your participation in this important AMCP Partnership Forum.

                               Sincerely,

                               Susan A. Cantrell, RPh, CAE
                               AMCP CEO
Biosimilars: Policy, Practice, and Post Marketing Surveillance to Support Treatment and Coverage Decisions - DEC. 15-16, 2020 | VIRTUAL - AMCP
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS

                                                                                                        MODERATOR

       Clifford Goodman, PhD
       Senior Vice President
       The Lewin Group

       Clifford Goodman, PhD, is a senior vice president at The Lewin Group. He has 30 years of
       experience in health technology assessment, evidence-based health care, health economics,
       and aspects of health care innovation, regulation, and payment. Dr. Goodman often serves as a
       health policy issues moderator and facilitator of expert panels and advisory boards. He served
       as chair of the CMS Medicare Evidence Development & Coverage Advisory Committee and
       president of the professional society, Health Technology Assessment International. He received
       his Doctorate in Philosophy from The Wharton School of the University of Pennsylvania and
       degrees from Georgia Tech and Cornell.

 AMCP PARTNERSHIP FORUM | DEC. 2020                                                                           PAGE 1
Biosimilars: Policy, Practice, and Post Marketing Surveillance to Support Treatment and Coverage Decisions - DEC. 15-16, 2020 | VIRTUAL - AMCP
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS

AGENDA

         TUESDAY, DEC. 15

12-5pm ET           Welcome and introductions

                    Presentation: Perspectives on biosimilars

                    Panel discussion: Exploring the challenges and facts about biologics and
                    biosimilars in the United States

                    Breakout session 1: Strategies and messaging to increase access and
                    adoption of biosimilars

                    Report out and discussion

                                  HOSTED BY AMCP IN PARTNERSHIP WITH

PAGE 2                                                           AMCP PARTNERSHIP FORUM | DEC. 2020
Biosimilars: Policy, Practice, and Post Marketing Surveillance to Support Treatment and Coverage Decisions - DEC. 15-16, 2020 | VIRTUAL - AMCP
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS

                                                                                      AGENDA

        WEDNESDAY, DEC. 16

12-5pm ET           Welcome and day 1 debrief

                    Panel discussion: What is working in the world of biosimilars?

                    Breakout session 2: Strategies and real-world evidence needs and opportunities
                    to help with biosimilar adoption

                    Report out and discussion

                    Forum summary and close

 AMCP PARTNERSHIP FORUM | DEC. 2020                                                                  PAGE 3
Biosimilars: Policy, Practice, and Post Marketing Surveillance to Support Treatment and Coverage Decisions - DEC. 15-16, 2020 | VIRTUAL - AMCP
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS

PARTICIPANTS

Christina Barrington, RPh,                     Diana Brixner, RPh, PhD,                           Mary Jo Carden, JD
PharmD                                         FAMCP                                              Head of Policy
                                                                                                  Sandoz
Vice President of Pharmacy Programs            Professor
Priority Health                                Department of Pharmacotherapy
                                                                                                  Mary Jo Carden, JD, serves as the head
Christina Barrington, RPh, PharmD, has         Diana Brixner, RPh, PhD, FAMCP, is the             of policy for Sandoz. She joined Sandoz
more than 20 years of managed care             executive director at the University               in Sep. 2019 after serving in various
experience and is currently the vice           of Utah Pharmacotherapy Outcomes                   capacities at AMCP for six years, including
president of pharmacy programs for             Research Center. She is also a research            as vice president of government and
Priority Health, where she is responsible      associate at the Institute of Public               pharmacy affairs. She also has experience
for setting strategy for the pharmacy          Health, Medical Decision Making, and               in policy and government affairs in PBMs,
department and managing the                    Health Technology Assessment in the                retail pharmacies, and long-term care
pharmaceutical services budget across          Department of Public Health and Health             pharmacies. She holds a Bachelor of
the organization. In addition to her role      Technology Assessment at University                Science from University of Pittsburgh
in pharmacy management, Dr. Barrington         of Miami Information Technology. Her               and a Juris Doctor degree from Catholic
has conducted extensive research               appointment supports her international             University in Washington, D.C.
into the impact of value-based benefit         collaborations in oncology research,
designs and is a pioneer in risk-based         personalized medicine, and value
contracting strategies. She has presented      assessment. Dr. Brixner is a founding
her research and innovative contracting        member of the Health Policy and Science
strategies at a variety of conferences.        Council, where she also served on the
Additionally, she has served as the vice-      executive board. She is also a past
chairman of the board of managers for          president of the International Society
the Illinois Foundation of Quality Health      of Pharmacoeconomics and Outcomes
Care and is currently a member of the          Research. Dr. Brixner is a long-standing
URAC Measures Advisory Research                member and past president of AMCP.
Group. As an active member of AMCP             She currently serves as a director on
since 1996, Dr. Barrington has held the        the board for the Biologics & Biosimilars
office of president of the Midwest affiliate   Collective Intelligence Consortium (BBCIC).
for two terms and currently serves on the
finance committee.

PAGE 4                                                                                  AMCP PARTNERSHIP FORUM | DEC. 2020
Biosimilars: Policy, Practice, and Post Marketing Surveillance to Support Treatment and Coverage Decisions - DEC. 15-16, 2020 | VIRTUAL - AMCP
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS

                                                                                          PARTICIPANTS

Jack Cox                                    Joe Eggler                                     Erika Emerson
Senior Director                             Senior Director, Market Access                 Executive Director
Nova Nordisk Inc.                           Account Management                             Diabetes Leadership Council
                                            Fresenius Kabi

Jack Cox is a senior director of market                                                    Erika B. Emerson is executive director
                                            Joe Eggler has 30 years of health care
access and trade strategy at Novo                                                          of the Diabetes Leadership Council. She
                                            experience in both pharmaceutical and
Nordisk. Jack as more than 30 years                                                        has more than 20 years of health policy
                                            molecular diagnostics. During this time,
experience in pharmaceutical, biotech,                                                     and advocacy experience, including
                                            he has held positions ranging from sales,
and distribution channels and has worked                                                   health care and pharmaceutical public
                                            marketing, new product development,
in marketing, operations, business                                                         policy, issues management, strategic
                                            sales management, payer account
development, and market access. He                                                         communications, and stakeholder
                                            management, executive level commercial
joined Novo Nordisk in 2012 and is                                                         relations. Her pharmaceutical industry
                                            operations, market access, and patient
currently responsible for payer marketing                                                  experience and knowledge of the U.S.
                                            and provider support programs. He has
and pricing/contracting strategy for the                                                   health care system lend unique insight
                                            worked in various companies starting
insulin and biopharm franchise teams.                                                      on state and federal policies impacting
                                            with TAP pharmaceuticals, Prometheus
Prior to joining Novo Nordisk, he worked                                                   access, quality and value of care and
                                            Laboratories, Provista Diagnostics, Lash
at Accredo Specialty Pharmacy as vice                                                      coverage for people with chronic
                                            Group, and Fresenius Kabi. Joe is currently
president, business development where                                                      conditions. Erika holds a Masters in Public
                                            the senior director, payer account
he led the strategy development for                                                        Policy from the Harvard Kennedy School
                                            management at Fresenius Kabi and leads
pipeline products, managed manufacturer                                                    and a bachelor’s degree in journalism and
                                            the team that prepares the launch of
relations, and contract negotiations. He                                                   political science from the University of
                                            several biosimilars.
earned his Bachelor of Science from                                                        Wisconsin-Madison.
Bowling Green State University and his
Master in Business Administration from
Marshall University.

  AMCP PARTNERSHIP FORUM | DEC. 2020                                                                                        PAGE 5
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BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS

PARTICIPANTS

 Alison Falb, JD                               Anna Hyde                                             Jim Kenney, RPh, MBA
 Regulatory Counsel                            Vice President of Advocacy and Access                 President
 FDA                                           Arthritis Foundation                                  JTKENNEY LLC

 Alison Falb, JD, is a regulatory counsel in   Anna Hyde is the vice president of                    Jim Kenney, RPh, MBA, is founder
 the FDA Center for Drug Evaluation and        advocacy and access at the Arthritis                  and president of JTKENNEY LLC, a
 Research’s (CDER) Office of Therapeutic       Foundation. She oversees grassroots                   managed care pharmacy consulting
 Biologics and Biosimilars, which oversees     engagement and both the federal and                   practice in Waltham, Mass. Jim worked
 the development and implementation            state legislative programs. Her focus is to           for Harvard Pilgrim Health Care for 38
 of regulatory policy related to biosimilar,   raise the visibility of arthritis as a public         years in pharmacy management, most
 interchangeable, or other therapeutic         health priority; build support for federal            recently as the manager of specialty
 biologic products. Prior to joining the       and state legislation that ensures access             and pharmacy contracts. Jim has
 Office of Therapeutic Biologics and           to affordable, high-quality health care;              received national recognition for the
 Biosimilars, Alison was a senior advisor      and enhance patient engagement in the                 development of value and outcomes-
 at the Center for Medicare and Medicaid       policy-making process. Anna worked as                 based contracts for pharmacy and
 Innovation at CMS where she led               senior manager for federal affairs at the             medical products. Jim is a pharmacy
 policy development for specialty care         American Congress of Obstetricians and                preceptor for the Massachusetts
 and episode-based payment models              Gynecologists. She began her health                   College of Pharmacy and Health
 under the Medicare Access and CHIP            policy career as a congressional fellow               Sciences. He currently serves on the
 Reauthorization Act of 2015 statute and       for Energy and Commerce Committee                     Massachusetts Pharmacists Association
 designed and implemented alternative          members, where she drafted legislation                Government and Legislative Affairs
 payment models including the Oncology         and staffed committee activities. Anna                Committee. Jim is currently immediate
 Care Model.                                   received a Bachelor of Arts in history                past-president of AMCP, where he has
                                               from Southern Methodist University and                been an active member for 30 years
                                               Master in Arts in political science from              and has served on several committees.
                                               American University.

PAGE 6                                                                                   AMCP PARTNERSHIP FORUM | DEC. 2020
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BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS

                                                                                          PARTICIPANTS

Troy Koch, PharmD, MBA                      April Kunze, PharmD                            Paul Lakomski, BS,
Account Medical Lead                        Senior Director, Clinical Formulary            RPh, MBA
Takeda Pharmaceuticals                      Development and Trend Management
                                                                                           Pharmacy Services Manager
                                            Strategy
                                                                                           Aetna / CVS
                                            Prime Therapeutics
Troy Koch, PharmD, MBA, is currently
a director, account medical lead for                                                       Paul G. Lakomski, RPh MBA, is a pharmacy
                                            April Kunze, PharmD, is the senior
Takeda Pharmaceuticals. In his role, he                                                    services manager for Aetna/ CVS. In
                                            director of formulary development and
engages in scientific exchange regarding                                                   this role, he supports Aetna’s clients in
                                            trend management strategy at Prime
Takeda products with some of the top                                                       trend management, clinical programs,
                                            Therapeutics (Prime) and is responsible
corporate and national health plan and                                                     and benefit design for pharmacy.
                                            for evaluating and communicating clinical
PBMs. Dr. Koch has an extensive career                                                     Previously, Paul was a director of account
                                            and financial decision making models
in the pharmaceutical and managed care                                                     management-MCO for Catamaran;
                                            for multiple formularies. She leads trend
industries, holding positions previously                                                   pharmacy director for Empire Blue Cross
                                            management activities and analyzes the
with Humana, Medimpact, and Hobart                                                         Blue Shield and Anthem New Hampshire;
                                            value of formulary changes, utilization
Core (now Precision for Value). He                                                         director account management regional
                                            management, and other clinical programs.
earned a Doctor of Pharmacy degree                                                         for WellPoint NextRx; drug utilization
                                            She also oversees Prime’s pipeline division
from the University of Kentucky, a Master                                                  review director, pharmacy director, and
                                            and proactively develops strategies to
of Business Administration from the                                                        director of network management for
                                            manage new, high-cost drug approvals.
University of Louisville, and completed a                                                  Excellus Blue Cross Blue Shield. He is as
                                            Prior to joining Prime in 2004, Dr. Kunze
residency in managed care pharmacy with                                                    subject matter expert regarding clinical
                                            worked for a home infusion company
Humana Inc.                                                                                programs, pharmacy cost drivers, trends,
                                            where she gained insights to many specialty
                                                                                           and pharmacy/ medical benefit products.
                                            drugs and disease states. She also acquired
                                            expertise in clinical patient management.

  AMCP PARTNERSHIP FORUM | DEC. 2020                                                                                        PAGE 7
Biosimilars: Policy, Practice, and Post Marketing Surveillance to Support Treatment and Coverage Decisions - DEC. 15-16, 2020 | VIRTUAL - AMCP
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS

PARTICIPANTS

Jeffrey (Jeff) Larson, RPh,                  Molly Billstein Leber,                           Hannah Lynch, MPS
MS, MBA                                      PharmD, BCPS, FASHP                              Associate Director, Federal Government
                                                                                              Relations and Health Policy
Clinical Director                            Associate Director, Drug Use Policy and
                                                                                              National Psoriasis Foundation (NPF)
CVS Health                                   Formulary Management
                                             Yale New Haven Health
                                                                                              Hannah Lynch, MPS, is the associate
Jeff Larson, RPh, MS, MBA, is a clinical
                                             Molly Billstein Leber, PharmD, MBA,              director of federal government relations
director and supervises a team of clinical
                                             BCPS, FASHP, is the associate director           and health policy for NPF. In this role, she
advisors who are responsible for the
                                             of drug use policy and formulary                 directs NPF’s legislative and regulatory
clinical programs and clinical management
                                             management at Yale New Haven Health              efforts at the federal level, develops the
services provided to CVS Health clients
                                             System. In this role, she is responsible         foundation’s federal policy positions,
in the health plan market segment. Jeff
                                             for standardizing safe and cost-effective        and represents NPF on several national
joined CVS Health in 1994 and is currently
                                             medication therapy across the system.            coalitions. Prior to her current role, she
based in Minneapolis. Prior to joining
                                                                                              worked for the Biotechnology Innovation
the company, Mr. Larson completed a
                                                                                              Organization (BIO) as manager of health
two-year management residency at the VA
                                                                                              care policy and research, focusing
Medical Center, Minneapolis concurrent
                                                                                              primarily on Medicare, Medicaid, and
with graduate work at the University of
                                                                                              drug reimbursement policy. She also
Minnesota. Jeff earned his Bachelor of
                                                                                              spent time with the National Alliance of
Science in pharmacy from North Dakota
                                                                                              State Health CO-OPs and on Capitol Hill.
State University, his Master of Science in
                                                                                              Hannah received a Master of Professional
hospital pharmacy from the University
                                                                                              Studies in legislative affairs from The
of Minnesota, and a Master in Business
                                                                                              George Washington University, and a
Administration from the University of
                                                                                              Bachelor of Science in political science
St. Thomas. He is an active member of
                                                                                              (pre-law) from The University of North
AMCP and has served on multiple AMCP
                                                                                              Carolina at Greensboro.
committees, including former committee
leadership positions.

PAGE 8                                                                              AMCP PARTNERSHIP FORUM | DEC. 2020
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS

                                                                                         PARTICIPANTS

George Mayzell, MD, MBA                      Dorothy McCabe, PhD, FCP                     Corey McEwen, PharmD, MS
President                                    Executive Director, CDMA, Specialty Care     Director, Oncology Pharmacy Services
Empowered Healthcare                         Boehringer Ingelheim Pharmaceuticals Inc.    Massachusetts General Hospital

George Mayzell, MD, MBA, is the founder      Dorothy McCabe, PhD, FCP, is executive       Corey McEwen, PharmD, MS, is the
and president of Empowered Healthcare,       director of clinical development             director of oncology pharmacy services
which specializes in population health,      and medical affairs, specialty care          at Massachusetts General Hospital.
care management redesign, clinical           organization at Boehringer Ingelheim         In this role, he oversees clinical and
variation, and clinical integration. Dr.     Pharmaceuticals. She provides medical/       operational pharmacy services for the
Mayzell was the past chief clinical          scientific, technical, and strategic         oncology pharmacy service line including
officer of Vizient Southeast and senior      directions to the plans, programs, and       inpatient oncology pharmacy, the
vice president/chief medical officer         procedures within the inflammation           main campus infusion center, and two
and chief clinical integration officer for   therapeutic and indication areas with        regional infusion centers in the greater
AMITA Health. AMITA Health is a joint        a focus on biosimilar development.           Boston area. Additionally, Dr. McEwen
operating company formed in Feb. 2015        She has over 35 years experience             has oversight of the pharmacy clinical
by Adventist Midwest Health and Alexian      leading product development and              trials programs which support the largest
Brothers Health System, encompassing         innovation in both small-molecule and        hospital-based research program in
nine hospitals and an extensive physician    biological compounds. Dr. McCabe             the country. He completed his two-year
provider network of more than 3,000          has broad multidisciplinary science          health system pharmacy administration
physicians. Dr. Mayzell joined Adventist     and medicine expertise. She has held         residency at the Cleveland Clinic in
Midwest Health in Jan. 2013 after serving    leadership positions in medical affairs      Cleveland. He received Master of
as CEO of Health Choice and senior           and new product development at               Science in health system pharmacy
vice president of Methodist Le Bonheur       several pharmaceutical companies and         administration from Northeast Ohio
Healthcare in Memphis, Tenn. He received     has been involved in many regulatory         Medical University and received his
his medical degree from Rutgers and his      interactions and strategies leading to       Doctor of Pharmacy from the University
Master in Business Administration from       commercial success.                          of Mississippi.
Jacksonville University.

  AMCP PARTNERSHIP FORUM | DEC. 2020                                                                                        PAGE 9
BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS

PARTICIPANTS

Ann McNamara, PharmD                          Therese Mulvey, MD, FASCO                          Farhana Naz, BS
Director of Clinical Development              Director Quality Safety and Value                  Senior Director Strategy
Fairview                                      MGH Cancer Center                                  Fresenius Kabi
                                              MGH

Ann McNamara, PharmD, is director of                                                             Farhana Naz, BS, has more 25 years of
                                              Therese Mulvey, MD, FASCO, is a medical
clinical development within the specialty                                                        experience in the health care industry
                                              oncologist specializing in breast cancer at
development team at Fairview Specialty                                                           analyzing evidence and cost value
                                              Massachusetts General Hospital (MGH).
Pharmacy. Dr. McNamara has worked at                                                             propositions for drug coverage decisions.
                                              She is the director of quality, safety, and
Fairview Specialty Pharmacy since Sep.                                                           Her experience includes pharmaceutical
                                              value for the cancer center and its nine
2004. She is responsible for the direction                                                       product strategy support at Anthem,
                                              affiliated network sites. She recently
and oversight of clinical development,                                                           Express Scripts, Aetna, Cardinal Health,
                                              co-chaired the MGH Oncology Pharmacy
therapy management, adherence                                                                    and Proctor & Gamble pharmaceuticals.
                                              and Therapeutics Safey Committee
programs, waste management strategies,
                                              (PTSC) and serves on the MGH Brigham
clinical reporting, and specialty pipeline
                                              Oncology PTSC. Dr. Mulvey is an active
monitoring. She provides clinical support
                                              volunteer for the American Society of
for payer strategies, payer quarterly
                                              Clinical Oncologists, where she currently
business reviews, and manufacturer
                                              serves as the immediate past chair of its
initiatives. Prior to her current position,
                                              quality-of-care council and is a member of
she was the director of the clinical
                                              the telehealth task force. She is the author
specialist team at Express Scripts. She
                                              of many papers concerning care delivery
received her Doctor of Pharmacy at the
                                              and improving cancer care.
University of Minnesota and completed an
ambulatory residency at St. Paul Ramsey
Medical Center.

P A G E 10                                                                             AMCP PARTNERSHIP FORUM | DEC. 2020
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                                                                                          PARTICIPANTS

Sonia Oskouei, PharmD,                       Gary Owens, MD                                Chad Pettit, MBA
BCMAS, DPLA                                  President                                     Executive Director, Marketing
                                             Gary Owens Associates                         Amgen
Vice President, Biosimilars
Cardinal Health
                                             Gary Owens, MD, was actively involved         Chad Pettit, MBA is the executive
Sonia T. Oskouei, PharmD, BCMAS,             in the managed care movement of the           director of marketing for Amgen’s
DPLA, serves as the vice president of        1990s, which evolved to the current era       biosimilars business unit and leads the
biosimilars for Cardinal Health, where       of health care coverage and payment           global biosimilars commercial team
she leads the organization’s biosimilar      reform. Dr. Owens served as the vice          in developing global launch strategy
strategy. Previously, Dr. Oskouei served     president of medical management and           for Amgen’s portfolio of biosimilar
as vice president of innovation and          policy at Independence Blue Cross for         medicines. He serves as a liaison with
digital health at Premier Inc. and led the   22 years. Forming his own consulting          the biopharmaceutical industry on policy
national biosimilars strategy on behalf of   practice in 2007, Dr. Owens provides          matters in biosimilars, a rapidly growing
4,000 hospitals and more than 175,000        strategic and tactical consulting services    segment of the Amgen business. With
other provider types. Prior to her work at   to a wide range of clients, including         his global experience, Chad has broad
Premier, Dr. Oskouei oversaw pharmacy        pharmaceutical manufacturers, device          perspective and is recognized as an
purchasing and procurement at Novant         manufacturers, and other developers           expert on biosimilar commercialization,
Health, a four-state integrated delivery     of new technology. Dr. Owens is the           market access for biosimilars, and the
network. She received her Doctor of          past chair of the Arthritis Foundation        policy measures required to facilitate
Pharmacy from Belmont University, and        of Eastern Pennsylvania, where he was         cost savings for patients and the
completed post-graduate residencies          a former member of the foundation’s           health care system over the long run.
in clinical pharmacy and health system       northeast regional board of directors.        Chad received his Master in Business
pharmacy administration.                     In addition. Dr. Owens was the first          Administration from the University of
                                             physician to serve as a board member          California Los Angeles, Anderson School
                                             for AMCP from 2014 to 2018.                   of Management, and holds a Bachelor of
                                                                                           Science in chemical engineering from the
                                                                                           University of California Davis.

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AA
P GR
   ETNID
       CAIPANTS

 Laura Pizzi, PharmD, MPH                       Ronald Piervincenzi, PhD                        Jim Rebello
 Director and Professor                         Chief Executive Officer                         Vice President, Formulary Strategy
 Rutgers University—Health Outcomes, Policy,    United States Pharmacopeia (USP)                Magellan Rx Management
 and Economics (HOPE) Program

                                                Ronald T. Piervincenzi, PhD, has served         Jim Rebello is currently the vice president
 Laura Pizzi, PharmD, MPH, is a seasoned
                                                as chief executive officer of USP since         of formulary strategy for Magellan Rx
 evaluation scientist and professor and
                                                2014. Under his leadership, USP has             Management underneath the MRx
 director of the Center for Health Outcomes,
                                                modernized its operations and launched          Specialty division. He works with payers to
 Policy, and Economics at Rutgers University.
                                                innovative new science, including in digital    provide valuable solutions for formulary
 She has led interdisciplinary teams to
                                                medicine, cutting-edge manufacturing            management to find savings in the high-
 develop and conduct cost and outcome
                                                technologies, and advanced biologics.           trending specialty space on both the
 analyses on pharmacological therapies as
                                                Before joining USP, Dr. Piervincenzi served     pharmacy and medical benefits. Jim is a
 well as a variety of non-pharmacological
                                                as vice president of development sciences       pharmacist with more than a decade of
 interventions. She has testified before
                                                with Biogen Idec Inc. and was a partner         managed care experience working directly
 the U.S. House of Representatives
                                                and leader in McKinsey & Company’s              with health plans and employers. Jim
 Committee on Ways and Means on
                                                global pharmaceutical and medical               received his Doctor of Pharmacy at the
 Medicare overspending in beneficiaries
                                                products practice for more than 12 years.       University of Rhode Island and also served
 with end-stage renal disease. Dr. Pizzi is
                                                Dr. Piervincenzi earned his Doctorate           in the U.S. Air Force.
 editor in chief of Value and Outcomes
                                                in Philosophy and Master of Science
 spotlight, member of the editorial board
                                                from Duke University in biomedical
 for PharmacoEconomics, deputy editor
                                                engineering, with research focused on
 of American Health and Drug Benefits,
                                                protein engineering.
 co-chair of the Cross-Council Workgroup
 on Competencies for New Professionals in
 Health Economics and Outcomes Research,
 and chair of the Common Economic
 Measures Workgroup for a new CDC-
 funded multi-center grant on glaucoma.

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                                                                                             PARTIC
                                                                                                  A IGPEANNDT A
                                                                                                              S

Carly Rodriguez, PharmD,                     Elizabeth Sampsel, PharmD,                        Marissa Schlaifer, MS, RPh
FAMCP                                        MBA, BCPS                                         Vice President, Policy and Regulatory Affairs
                                                                                               OptumRx
Pharmacy Director, Clinical Innovation       Clinical Program Manager
Moda Health                                  MedImpact Healthcare Systems Inc.
                                                                                               Marissa Schlaifer, MS, RPh, currently
Carly Rodriguez, PharmD, FAMCP, is           Elizabeth Sampsel, PharmD, MBA, BCPS,             serves as vice president, policy and
pharmacy director, clinical innovation       provides clinical consultative services           regulatory affairs at OptumRx, where
for Moda Health. She provides                for MedImpact to health plans, including          she’s responsible for public policy related
strategic leadership for clinical            P&T support and quality measure                   to OptumRx’s PBM and home delivery,
initiatives, operations, innovation, and     optimization to assist clients with achieving     specialty, home infusion, compounding,
the integration and management of            overall improved health outcomes at the           and community mental health
medications across pharmacy and              lowest possible net cost. Dr. Sampsel             pharmacies. Prior to her current position,
medical benefits. Her areas of expertise     has supported clients over numerous               she worked as an independent consultant
include formulary management, cost-          lines of business, including commercial,          focused on health care policy analysis,
savings and utilization management           government programs, and employer                 issue advocacy, practice advancement
strategies, specialty drug management,       groups. Dr. Sampsel has more than                 and business development. Previously,
benefit design, and medical pharmacy.        20 years of pharmacist experience in              Marissa served as the head of policy in
She has presented to a variety of            various settings, including PBM, health           the government affairs department for
audiences on important topics in             plan, and health systems and with the             a major PBM and pharmacy innovation
managed care, such as specialty              FormularyDecisions platform. She currently        company, and as director of pharmacy
pharmacy, data integration, oncology,        serves on the AMCP legislative and                and regulatory affairs at AMCP. Marissa
and trend management. Dr. Rodriguez          regulatory advisory committee, leads the          currently serves as AMCP President.
received her Doctor of Pharmacy from         COVID-19 subcommittee, and has been a
the University of Washington, School         national judge for the AMCP Foundation
of Pharmacy, along with a certificate in     P&T Competition for 10 years.
biomedical and regulatory affairs. She was
recognized as a fellow of AMCPin 2019 for
exceptional contribution, commitment,
and sustained excellence in managed
care pharmacy.

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PARTICIPANTS

 Christine Simmon, JD                          Eva Temkin, JD                                      Jaap Venema, PhD
 Senior Vice President, Policy and Strategic   Acting Director for Policy                          Executive Vice President and
 Alliances and Executive Director,             FDA, CDER, Office of Therapeutics                   Chief Science Officer
 Biosimilars Council                           and Biologics                                       USP
 Association for Accessible Medicines (AAM)

                                               Eva Temkin, JD, is the acting director              Jaap Venema, PhD, is the executive vice
 Christine Simmon, JD, joined the
                                               for policy in the FDA CDER’s Office of              president and chief science officer for
 Association for Accessible Medicines
                                               Therapeutics and Biologics. She oversees            USP, where he leads the organization’s
 in 2012 as the senior vice president of
                                               the development and implementation                  scientific strategy and development of
 policy and strategic alliances and most
                                               of policy related biological products. Eva          quality standards for medicines, dietary
 recently was named executive director
                                               leads FDA’s Biosimilar Action Plan, which           supplements, food ingredients, and
 of AAM’s Biosimilars Council, which was
                                               outlines the administration’s plans for             health care practice. Dr. Venema oversees
 founded in 2015. Christine is responsible
                                               encouraging innovation and competition              implementation of the USP Science
 for leading policy development and
                                               among biologics and the development                 Quality Framework, which grounds quality
 issues management for AAM, directing
                                               of biosimilars. She also works on patient           standards development in pharmaceutical
 the Biosimilars Council, and building
                                               access. Previously, Eva was associate chief         science to increase public trust in
 relationships with strategic partners in
                                               counsel for drugs in FDA’s Office of Chief          medicines. He guides exploration of
 the health care sector, including patient
                                               Counsel and counseled on numerous                   emerging technologies that may inform
 advocacy groups. Christine previously
                                               biomedical products issues, including               future quality standards; serves as chair
 served as vice president of policy, public
                                               expedited pathways, data development                of USP’s council of experts; and oversees
 affairs and development at AAM from
                                               questions, and evidentiary standards to             collaborations with other pharmacopeial
 2002 to 2006. Before rejoining the
                                               over-the-counter monograph reform. Eva              and scientific groups. Dr. Venema
 association, she was the senior director
                                               was a former litigator at Cravath, Swaine &         previously served in scientific leadership
 of public policy for CVS Caremark, where
                                               Moore LLP and Robbins, Russell, Englert,            positions at Solvay and AbbVie (formerly
 she was the policy lead for the integrated
                                               Orseck, Untereiner & Sauber LLP. She was            Abbott Laboratories). Dr. Venema earned
 retail, convenient care clinic, and
                                               also a law clerk in the U.S. District Court         a master’s degree in chemistry from the
 pharmacy benefit manager enterprise at
                                               for the Eastern District of New York.               Free University of Amsterdam, and a
 both the state and federal levels.
                                                                                                   Doctorate of Philosophy in biochemistry
                                                                                                   and molecular biology from Leiden
                                                                                                   University in the Netherlands.

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BIOSIMILARS: POLICY, PRACTICE, AND POST MARKETING SURVEILLANCE TO SUPPORT TREATMENT AND COVERAGE DECISIONS

                                                                                              PARTICIPANTS

Randy Vogenberg,                                Erin Wright, PharmD, BCPS
PhD, RPh                                        Director, Field Pharmacy
                                                Premier Inc.
Principal and Board Chair
Institute for Integrated Healthcare (IIH) and
Employer-Provider Interface Council (EPIC)      Erin Wright, PharmD, BCPS, is a director
                                                with the field pharmacy team at Premier
Randy Vogenberg, PhD, RPh, is principal
                                                Inc. She is responsible for providing
of IIH. Previously, he was the senior vice
                                                expertise regarding Premier’s service and
president and thought leader for Aon
                                                contract portfolios to Premier members
Consulting North America. He currently
                                                and serves as the primary liaison on all
serves as board chair for the EPIC
                                                pharmacy-specific initiatives. Dr. Wright
for the Hospital Quality Foundation;
                                                serves Premier’s field team as the clinical
co-leader for the National Employer
                                                resource on biosimilars. She was a clinical
Biologics & Specialty Initiative, Midwest
                                                and operations coordinator at a large
Business Group on Health; and fellow
                                                academic medical center for 14 years
for the Foundation for HealthSmart
                                                before joining Premier in December
Consumers. His work for self-funded
                                                2019. Dr. Wright received her Doctor of
employers include innovative contracting,
                                                Pharmacy from Purdue University and
compliance, and holistic care cost
                                                she is an active member of the American
management or research to drive high
                                                Society of Health System Pharmacists
performing plans. His expertise in
                                                as well as the Florida Society of Health
commercial/employer benefits and care
                                                System Pharmacists.
delivery issues has produced several
books, publications, and presentations
in peer-reviewed and non-peer reviewed
venues. He continues collaborations
with various universities, including three
adjunct faculty appointments and guest
lectureships on his areas of expertise.

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A M C P S T A F F & C O N S U LT A N T S / T H A N K Y O U

Susan A. Cantrell, RPh, CAE
Chief Executive Officer

                                                                 Thank You
Phil Bongiorno
Vice President, Policy & Government Relations       To our distinguished participants and guests.

Thomas Casey
Senior Policy & Government Relations Coordinator                          •

Liz Colangelo
Senior Manager, Business Strategies
                                                               About AMCP
                                                    AMCP is the professional association leading
Vyishali Dharbhamalla, PharmD
Manager, Professional Affairs                       the way to help patients get the medications
                                                    they need at a cost they can afford. AMCP’s
Abigail Fredenburg, MA
Director of Integrated Marketing                        diverse membership of pharmacists,
& Communications
                                                    physicians, nurses, and professionals in life
Julian Greer, CMP                                   sciences and biopharmaceutical companies
Senior Manager, Meetings and Forums
                                                       leverage their specialized expertise in
Nicholas Ladikos, PharmD, BCPS,                     clinical evidence and economics to optimize
BCGP, BCIDP                                          medication benefit design and population
Director of Professional Affairs
                                                   health management, and help patients access
Cate Lockhart, PharmD, PhD                         cost-effective and safe medications and other
Executive Director
                                                   therapies. AMCP members improve the lives of
Matt Lowe                                          nearly 300 million Americans served by private
Vice President, Business Strategies
                                                         and public health plans, pharmacy
Noreen Matthews, BSN, MBA                                 benefit management firms, and
Senior Business Consultant                                    emerging care models.

Cynthia Reilly, MS, BS Pharm
Chief Operating Officer                                                   •

Terry Richardson, PharmD, BCACP                               AMCP Mission
Senior Pharmacist Consultant

                                                   To improve patient health by ensuring access
Ruby Singh, PharmD, BCPS
Vice President, Education and Training
                                                     to high-quality, cost-effective medications
                                                                and other therapies.

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                                                                                          NOTES

 AMCP PARTNERSHIP FORUM | DEC. 2020                                                             P A G E 17
AMCP | Academy of Managed Care Pharmacy      Findings and recommendations from this
                                          event will be published in an upcoming issue
675 N Washington Street | Suite 220       of AMCP’s Journal of Managed Care + Specialty
Alexandria, VA 22314
                                          Pharmacy and will be widely disseminated to
703 684 2600 | www.amcp.org | @amcporg            decision makers around the country.
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